Medtronic, Inc. is facing three new surgical stapler lawsuits that accuse the company of selling defective devices and concealing their risks.
All three complaints were filed in December, including two cases in Minnesota’s Hennepin County District Court by plaintiffs from Texas and Iowa. Another plaintiff from the Lone Star State filed the third case in the U.S. District Court, Eastern District of Texas.
According to the Minneapolis Star-Tribune, each of the plaintiffs underwent gastrointestinal surgery in December 2017 that required the precise placement of staples in their organs. In each case, Medtronic’s surgical staplers allegedly malfunctioned by creating holes without leaving behind staples or not properly closing implanted staples. As a result, the plaintiffs suffered adverse events, including severe infections and cardiac problems, were forced to undergo corrective surgeries, and incurred hundreds of thousands of dollars in additional medical expenses.
“A reasonable and prudent manufacturer is or should be aware of the risk that if its product is defective, the [surgical] repair it is intended to secure could break loose, causing the contents of an organ undergoing repair to be released into the surrounding area of the body,” one of the Hennepin County filings asserted.
The surgical stapler lawsuits further claim that Medtronic intentionally took advantage of the U.S. Food & Drug Administration’s (FDA) virtually unknown alternative summary report (ASR) program to bury injury reports and conceal the staplers’ true risks from doctors and patients.
The FDA requires medical device makers to file adverse event reports with the agency. But until last year, the ASR program allowed companies to file spread sheets summarizing large numbers of injuries with little in the way of detail, provided the agency agreed the adverse events were “well-known and well-established risks associated with a particular device.”
According to the Star-Tribune, Medtronic was a “prolific user” of the ASR program until 2016.
Last year, the FDA finally released information on more than 5.7 million device-related injuries or malfunctions reported to the ASR program since 1999, including tens of thousands of reports that cited Medtronic and Covidien surgical staplers. A subsequent review found that while 109,997 adverse events involving all models of surgical staplers had been reported to the agency between 2011 and 2018, only 53,740 had been publicly reported.
Although surgical staples used in gastrointestinal surgeries and other internal procedures had long been classified as low risk (class I) medical devices, the FDA recently proposed reclassifying internal surgical staplers as moderate risk (class II) devices, which would subject the devices to additional regulatory oversight.